Browsing by Author "Krogh, NS"

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    Efficacy and Safety of CT-P13 as First- and Second-Line Treatment in Patients with Ankylosing Spondylitis
    Uslu, S; Gülle, S; Sen, G; Capar, S; Senel, S; Dalkilic, E; Akar, S; Koca, SS; Tufan, A; Yazici, A; Yilmaz, S; Inanc, N; Birlik, M; Solmaz, D; Cefle, A; Goker, B; Direskeneli, H; Yolbas, S; Krogh, NS; Yilmaz, N; Erten, S; Bes, C; Gündüz, OS; Oztürk, MA; Haznedaroglu, S; Yavuz, S; Onen, F; Sari, I
    Background/Objectives: CT-P13 is a biosimilar version of infliximab, a monoclonal antibody. In individuals with ankylosing spondylitis (AS), CT-P13 has been shown to be effective and to have a well-tolerated safety profile. The aim of this study was to evaluate the long-term drug persistence, safety, and efficacy of infliximab biosimilar CT-P13 in patients with AS undergoing first-line (1st-line) and later (>= 2nd-line) treatment in clinical practice. Methods: We performed an observational cohort study that included AS patients based on the biological drug database in the TURKBIO Registry between 2014 and 2021. The patients were divided into two groups: those receiving CT-P13 as first-line treatment or as a switch (>= 2nd-line) from another TNF inhibitor (TNFi). Standard disease activity metrics were used to assess the effectiveness of CT-P13, and drug retention rates were investigated. Results: There were 179 AS patients using CT-P13 (47.4% male, mean age: 42.9 +/- 11.3 years). Of these patients, 123 (68.7%) were receiving CT-P13 as a first-line treatment. The mean length of treatment was 3.5 years. CT-P13 drug retention rates in the general patient population were 58.6% and 48.2% in the first-line and >= second-line treatment, respectively, after 3 years of follow-up. The most common reason for CT-P13 treatment discontinuation was lack of efficacy. The first-line CT-P13 group had statistically substantially higher ASAS20/40 response rates at three and six months. Nonetheless, both groups' response rates at one year were comparable. Conclusions: In this real-world data analysis, AS patients who were TNFi na & iuml;ve (1st-line) and subsequently treated (>= 2nd-line) with CT-P13 showed encouraging drug retention rates with acceptable long-term effectiveness and safety.
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    A real-life analysis of patients with rheumatologic diseases on biological treatments: Data from TURKBIO Registry
    Önen, F; Can, G; Çapar, S; Dalkiliç, E; Pehlivan, Y; Senel, S; Akar, S; Koca, SS; Tufan, A; Yazici, A; Yilmaz, S; Inanç, N; Sari, I; Birlik, M; Solmaz, D; Cefle, A; Öztürk, MA; Yolbas, S; Krogh, NS; Yilmaz, N; Erten, S; Bes, C; Gündüz, ÖS; Göker, B; Haznedaroglu, S; Yavuz, S; Çetin, GY; Yildiz, F; Direskeneli, H; Akkoç, N
    Objective: TURKBIO registry, established in 2011, is the first nationwide biological database in Turkey. This study aimed to provide an overview of TURKBIO data collected by June 2018. Methods: The registry included adult patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), nonradiographic axial spondyloarthritis (nr-AxSpA), and psoriatic arthritis (PsA). Demographic and clinical features, disease activity markers, and other follow-up parameters, current and previous treatments, and adverse events were registered electronically at each visit using open-source software. The registration of patient-reported outcome measures was carried out electronically by the patients using touch screens. Results: TURKBIO registry included a total of 41,145 treatment series with biologicals. There were 2,588 patients with axSpA (2,459 AS and 129 nr-axSpA), 2,036 with RA, and 428 with PsA. The total number of patients, including those with other diagnoses, was 5,718. In the follow-up period, the number of patients and also visits steadily increased by years. The yearly mean number of visits per patient was found to be 2.3. Significant improvements in disease activity and health assessment parameters were observed following the biological treatments. Biologics were often given in combination with a conventional synthetic disease-modifying antirheumatic drug in patients with RA. Infections were the most commonly seen adverse events, followed by allergic reactions. Tuberculosis was observed in 12 patients, malignancy in 18, and treatment-related mortality in 31. Conclusion: TURKBIO provided a valuable real-life experience with the use of biologics in rheumatic diseases in Turkey.
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    GENETIC SUSCEPTIBILITY AND PHENOTYPE OF RHEUMATOID ARTHRITIS IN DANISH AND TURKISH PATIENTS
    Lauridsen, KB; Linauskas, A; Rasmussen, C; Can, G; Onen, F; Dreyer, L; Steffensen, R; Nielsen, KR; Krogh, NS; Akar, S; Akkoc, N